As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years resisted calls to loosen its long-standing prohibitions on the off-label promotion of unapproved products, it has simultaneously recognized that truthful and non-misleading scientific or medical information coming from manufacturers about their own drug, biologic, and device products plays an important role in the U.S. health care system. This has especially been true in a climate where individual products are becoming more complex; precision medicine approaches to treating disease are gaining ground in clinical practice; and the health system is evolving into one more focused on outcomes and value-based arrangements between entities. The expansion of First Amendment commercial speech principles by the courts over the past decade and lawsuits against FDA also have pushed the Agency to move towards the potential reform of its existing off-label policies. Continue Reading Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

The Affordable Care Act (ACA) and the Medicare and CHIP Reauthorization Act (MACRA) provided the Centers for Medicare & Medicaid Services (CMS) and the newly created Center for Medicare and Medicaid Innovation (CMMI) tremendous authority. With Republicans set to take control of both the White House and Congress, the future of that authority is very much in question.

The ACA created CMMI to test innovative payment and service delivery models to reduce program expenditures and improve care. To carry out this goal, the ACA allows CMMI to waive any Medicare provision of the Social Security Act, as well as select Medicaid provisions, that may be necessary to carry out and evaluate demonstration policies. If the demonstrations prove effective, CMS may implement the program nationally.

Over the past few years, CMS has implemented numerous demonstration projects under CMMI’s authority. These include delivery reform demonstrations such as the Medicare Shared Savings Program and Pioneer ACO program, as well as the Financial Alignment Initiative, which integrates care for dual-eligible individuals in select states. Demonstrations such as the Medicare Advantage Value-Based Insurance Design Model have focused on encouraging the use of high-value clinical services, while others, such as the Diabetes Prevention Program, have focused on preventive service models. In July of this year, CMS proposed expanding the Diabetes Prevention Program nationally.

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act. Repeal and replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend. In doing so, Republicans must consider three important factors as they look at policy. The first two, talking with insurers and avoiding coverage disruption, were discussed in our prior blogs. The thirdis making hard choices.

The economist Thomas Sowell is often credited with this quote “There are no solutions, only tradeoffs.” In 2009, the Democrats made tradeoffs in constructing the Affordable Care Act. Now it will be the Republicans’ turn to make tradeoffs as they move to transition away from the Affordable Care Act. Republicans will consult stakeholders and experts and will engage the Congressional Budget Office, especially around coverage and costs. Republicans will then have to make hard choices based on the information they receive.

One specific example will involve Medicaid. Will Republicans reduce the special matching rate states receive to cover those who are newly eligible under the Affordable Care Act? They are certain to be told that drastically reducing the matching rate will cost millions of Americans their Medicaid coverage. States have made the decision to cover these low-income individuals, but if the payment is reduced, it is highly likely that state budgetary pressures will force many states to make the difficult decision of reducing or eliminating coverage.

Republicans are going to receive information about the coverage and cost consequence of their policy choices. They are going to be told things they may not have expected or wanted to hear. They will then have to decide if they want to reconsider or proceed and face the consequences.

In the end, Republicans are about to be able to engage in health care policy making in a way they weren’t in 2009. Republicans want to show they have a better way (the title of the House Republican platform). Their policies will produce coverage and cost numbers. They must decide then how they will proceed. Decisions will have consequences, and they will own those consequences.

In the coming days, we’ll be continuing to cover health care reform in the 115th Congress with a focus on specific health care programs. Stay tuned!

In non-election news, the Office for Civil Rights (OCR) at the Department of Health and Human Services recently released its November Cyber Awareness Newsletter. This month’s newsletter focuses on the topic of authentication. OCR encouraged health care companies to review and strengthen their authentication methods and other safeguards to avoid breaches of electronic protected health information (ePHI).

As is well known, drug prices have been widely discussed nationally. They have been the subject of Congressional hearings and, in the case of Mylan, a high profile settlement.

Massachusetts has also focused intently on drug prices in recent months. My colleagues in ML Strategies recently published an alert surveying the current Massachusetts landscape around drug pricing and spending. The alert discusses, among other things, the following developments:

The Center for Health Information and Analysis (CHIA) published its annual report on the performance of the Massachusetts health care system and addressed the growth of prescription drug spending.

The Office of Attorney General Maura Healey recently released her office’s annual report examining pharmaceutical cost trends in the Commonwealth.

The Massachusetts Health Policy Commission (HPC) discussed drug pricing extensively during its annual cost trends hearings on October 17th and 18th. In written testimony submitted before the cost trends hearings, both payers and providers expressed their view that rising pharmaceutical spending is a top area of concern (our full coverage of the cost trends hearing is here.)

Massachusetts state Senator Mark Montigny introduced An Act to Promote Transparency and Cost Control of Pharmaceutical Drug Prices (S. 1048), which aimed to control growth in prescription drug costs by mandating several pricing disclosure requirements. The bill failed to emerge from a legislative committee, but similar efforts addressing pharmaceutical spending are likely to emerge in the next legislative session.

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act. Repeal and replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend. In doing so, Republicans must consider three important factors as they look at policy. The first, talking with the insurers, was discussed in a previous post. The second is avoiding coverage disruption. As Republicans begin the process of transition, they must avoid policies that will cause severe coverage disruption.

For example, Republicans strongly oppose the individual mandate in the Affordable Care Act. The incoming Administration could order the IRS to create a number of “carve outs” for the individual mandate that would render it ineffective. While that is a policy choice, the consequence likely would be insurers exiting the marketplace. Without a mechanism to cause participation, the risk of adverse selection becomes unacceptably high—especially given the experience to date with the Affordable Care Act population.

Republicans do not want to cause millions of people to lose coverage, but, at the same time, they want to make significant changes in the policies of the Affordable Care Act. Republicans are going to have to make structured policy decisions to minimize coverage disruptions. After years of holding the Democrats responsible for their policy decisions, Republicans will now have to own the consequences of their policy decisions.

This post is the third in a series, with the first being published on Monday and the second being published on Tuesday. In the posts that follow, we will describe additional critical issues that Republicans must tackle as they transition the Affordable Care Act and the impact of the new Congress and new administration on certain hot topics in health reform.

Last week, the OIG posted its Work Plan for 2017. In it, the OIG announced many goals touching on programs including, but not limited to, Medicare, Medicaid, Insurance Marketplace (Health Exchanges), Indian Health Service, TANF and Head Start. Below are some of the OIG’s action items that Medicare Advantage and Part D plans should be aware of. As in years past, most of the OIG’s goals relating to the Medicare program focus on whether CMS is properly administering and monitoring the programs. Although the OIG often targets CMS, this focus can result in increased OIG and CMS scrutiny for plans and plans’ first tier, downstream, and related entities. Continue Reading 2017 OIG Work Plan: For Medicare Plans

As we look ahead to the 115th Congress, Republicans are likely to take up repeal and replacement of the Affordable Care Act. Repeal and replace is more accurately described as a transition where Republicans design a version of health care reform they will own and defend. In doing so, Republicans must consider three important factors as they look at policy, the first of which is talking to insurers. Continue Reading Transitioning the Affordable Care Act: Republicans Must Talk to Insurers

Last week, the Massachusetts Department of Public Health issued another round of proposed amendments to its regulations, continuing the Baker Administration’s regulatory reform efforts. Today, we take a closer look at the proposed amendments to the proposed regulations governing the licensure of hospice programs.

As expected, many of the proposed changes are aimed at making the hospice regulations consistent with the rules that govern other health facilities such as hospitals and clinics. For example, consistent with the hospital and clinic regulations, the Commissioner would be given broad authority to determine under what circumstances a change in control of the operation of the hospice rises to the level of a “transfer of ownership”. Another change for consistency purposes is the proposed revision to the rules governing incident reporting. Under the proposed rule, a hospice inpatient facility must report unanticipated deaths and any serious incidents or accidents as defined in guidelines of the Department. Continue Reading Massachusetts Licensure of Hospice Programs Proposed Regulations – Key Take-Aways

Associate Editor

Mintz Levin’s Health Law Practice

As the health care and life sciences industries continue to undergo sweeping regulatory change, your company might be facing unprecedented structural and operational challenges. Heightened government scrutiny of industry practices certainly adds to the complexity of operating in the market for all providers, payors, manufacturers, distributors, and suppliers.Read More